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Observational Study in Type 2 Diabetes Treated by an Intensive Insulin Treatment (ICT) Containing Once Daily Levemir® (Insulin Detemir) (LEONCET2)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00657930
First received: April 8, 2008
Last updated: June 27, 2012
Last verified: September 2011
History of Changes
  Purpose

This study is conducted in Europe. The aim of this observational study is to gain practical experience with once-daily Levemir administration in type 2 diabetes patients who were previously treated with Insulatard®, Humulin® N (NPH insulins) as basal insulin as part of their ICT under normal clinical practice conditions in Hungary.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
 Drug: insulin detemir

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation on Glycaemic Control and Weight Change of Once Daily Levemir® (Insulin Detemir) in Type 2 Diabetes Mellitus Treated by an Intensive Insulin Treatment (ICT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Efficacy (HbA1c) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Hypoglycaemia frequency [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • FBG variability [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Insulin dose change [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 2289
Study Start Date: March 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin detemir
observational study - dose and frequency to be prescribed by the physician as a result of standard clinical practice.
Other Name: Levemir®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult Type 2 Diabetes Mellitus patients on intensive insulin treatment

Criteria

Inclusion Criteria:

  • Type 2 diabetic subjects on intensive insulin treatment (ICT)
  • Eligibility for once daily insulin detemir administration
  • Informed consent obtained before any observation-related activities

Exclusion Criteria:

  • Known or suspected allergy to insulin detemir
  • Subjects previously enrolled in the observation
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within 6 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657930

Locations
Hungary
Budapest, Hungary, H-1025
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Peter Varnai Varnai, MD Novo Nordisk Hungary Ltd.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00657930     History of Changes
Other Study ID Numbers: NN304-3526
Study First Received: April 8, 2008
Last Updated: June 27, 2012
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013